TWI400062B - Medical devices that record physiological signals - Google Patents

Medical devices that record physiological signals Download PDF

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TWI400062B
TWI400062B TW096142272A TW96142272A TWI400062B TW I400062 B TWI400062 B TW I400062B TW 096142272 A TW096142272 A TW 096142272A TW 96142272 A TW96142272 A TW 96142272A TW I400062 B TWI400062 B TW I400062B
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signal
brain wave
ecg
medical device
circuit
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TW200920317A (en
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胡威志
徐良育
蘇振隆
繆紹綱
蔡育秀
李愛先
朱耀棠
陳紹田
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私立中原大學
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/333Recording apparatus specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/369Electroencephalography [EEG]

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  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Description

可記錄生理訊號之醫療裝置Medical device capable of recording physiological signals

本發明係有關於一種醫療裝置,其係尤指一種可記錄生理訊號之醫療裝置。The invention relates to a medical device, in particular to a medical device capable of recording physiological signals.

按,現今腦血管疾病與心臟疾病近年來已被高度重視,腦血管疾病與心臟疾病分別為主要死因中僅次於惡性腫瘤。目前在每年腦血管疾病發病人數日漸增加,心臟疾病、糖尿病、和高血壓更是引發腦中風的主要幫兇,如此高危險性的疾病,值得我們重視與關心。According to the present, cerebrovascular diseases and heart diseases have been highly valued in recent years, and cerebrovascular diseases and heart diseases are the only major causes of death after malignant tumors. At present, the number of cerebrovascular diseases is increasing every year. Heart disease, diabetes, and high blood pressure are the main accomplices of stroke. Such high-risk diseases deserve our attention and concern.

冠狀動脈心臟病乃為目前最普遍的慢性疾病之一,其發病率僅次於高血壓及腦中風。在文獻中有許多的報告提到冠狀動脈心臟病合併有腦部血管狹窄,因而引起冠狀血管繞道術或是氣球擴張術後神經病發症包括中風或長期的智力退化。核子醫學腦部掃描上的貫流障礙,也有證據跟這樣的併發症有關係。另一方面,冠狀動脈手術後,病患常會產生智力退化及其他神經學的併發症。其原因常歸咎於因冠心症所產生的心律不整(尤其是心房顫動),引起的微小梗塞,我們認為其他常常被忽略的重要可能原因,就是冠狀動脈心臟病患同是具有腦血管阻塞。Coronary heart disease is one of the most common chronic diseases, and its incidence is second only to hypertension and stroke. There are many reports in the literature that coronary heart disease combined with cerebral vascular stenosis, resulting in neuropathy after coronary artery bypass or balloon dilation, including stroke or long-term mental deterioration. There are also evidences of cross-flow disorders on the brain scan of nuclear medicine. On the other hand, after coronary surgery, patients often develop mental deterioration and other neurological complications. The cause is often attributed to a small infarction caused by arrhythmia (especially atrial fibrillation) caused by coronary heart disease. We believe that other important reasons that are often overlooked are that coronary heart disease patients have cerebrovascular obstruction.

當腦血管疾病的患者,大腦有了器質性病變或機能性異常時,神經細胞之電氣生理會遭受到影響,因而產生各種的腦電波變化。大腦產生病變時,神經細胞壞死失去原有之電氣活動,在範圍大的腦梗塞就可能會產生腦電波會消失或是振幅下降的情況。大腦半期病變處及其周圍產生θ、δ範圍的局部性徐波,通常較常者為多型性δ波(poly delta activity,簡稱PDA)。局部性徐波可能取代原有正常的腦電波,也可能與原有的背景腦電波混在一起。腦中風病變患者,其腦電波的變化可能會有多型性高振幅徐波、基本背景律波的減失、間歇規律性δ波等,有些急性期的腦中風病人會出現癲癇樣腦電波。當腦部有血塊存在時,會出現振幅大為降低之平坦型電波。腦部血管狹窄會導致腦部缺氧狀況,腦電圖變化受到缺氧嚴重程度及其短暫而有所不同,最嚴重時會出現α-昏迷(α-coma)、猝發-壓抑型腦波(burst-suppression pattern)或平坦腦電圖(flat EEG)。When a patient with cerebrovascular disease has an organic disease or a functional abnormality in the brain, the electrical physiology of the nerve cell is affected, and various brain wave changes are generated. When the brain produces lesions, the necrosis of the nerve cells loses the original electrical activity, and in the case of a large cerebral infarction, the brain wave may disappear or the amplitude may decrease. Local undulations of θ and δ are generated at and around the cerebral half-stage lesions, usually polymorphic delta (PDA). Localized Xu waves may replace the original normal brain waves, and may also be mixed with the original background brain waves. In patients with cerebral apoplexy, changes in brain waves may have polymorphic high amplitude Xu waves, loss of basic background rhythm waves, intermittent regular δ waves, etc. Some epileptic brain waves may occur in patients with acute stroke. When a blood clot is present in the brain, a flat type of electric wave whose amplitude is greatly reduced appears. Cerebral vascular stenosis can lead to hypoxia in the brain. EEG changes are affected by the severity of hypoxia and its transient. In the most severe cases, α-coma (a-coma), burst-repressed brain waves ( Burst-suppression pattern) or flat EEG.

心臟功能就像幫浦一樣,當心血管疾病的患者,有任何病灶所引發瓣膜破壞,增加心臟負擔以後,便會造成心臟疾病的症狀產生,不論是因為狹窄病變產生阻力,或是漏血即閉鎖不全的變化而使血流在心房、心室間上上下下回流,皆造成心臟本身負擔加重,一旦負擔加重,便呈現心臟衰竭的症狀。依照它本身的狹窄程度,或是閉鎖不全程度,而產生不同程度的症狀。當任何一個瓣膜有問題的話,會造成心室慢慢的擴大或肥厚,隨後便造成心臟本身負擔加重,就不能夠把含氧量極高的血液供給到全身去。這時到腦部血流或是到下肢血流不夠了,便產生腦部缺氧性症狀。血液缺氧輕者心率增快,心排血量及血壓會增加。嚴重缺氧時血壓、心率和心排血量下降,可發生心律紊亂,心室性纖維顫動和心臟驟停。所以當血管狹窄時心電圖中的心跳間期會受到缺氧嚴重程度而有不同的心率變化,腦部也會因為足缺氧狀況產生腦電波異常狀況。The heart function is like a pump. When a patient with cardiovascular disease has any disease caused by valve damage and increases the burden on the heart, it will cause symptoms of heart disease, whether it is due to resistance caused by stenosis or blockage of blood leakage. Incomplete changes cause the blood to flow back and forth between the atrium and the ventricles, causing the burden of the heart itself to increase. Once the burden is aggravated, symptoms of heart failure are present. According to its own degree of stenosis, or the degree of incomplete locking, it produces different degrees of symptoms. When there is a problem with any of the valves, it will cause the ventricles to slowly expand or become thick, and then the heart itself will be burdened, so that the blood with extremely high oxygen content cannot be supplied to the whole body. At this time, blood flow to the brain or blood flow to the lower limbs is insufficient, and symptoms of hypoxia in the brain are produced. When the blood is hypoxic, the heart rate increases, and the cardiac output and blood pressure increase. Blood pressure, heart rate, and cardiac output decreased during severe hypoxia, and heart rhythm disorders, ventricular fibrillation, and cardiac arrest may occur. Therefore, when the blood vessels are narrow, the heartbeat interval in the electrocardiogram will be affected by the severity of hypoxia and different heart rate changes, and the brain will also have abnormal brainwaves due to the lack of oxygen in the foot.

當心臟缺血時,輸送到腦部的血液不足,導致腦部產生缺氧的狀況,腦部缺氧的狀況嚴重程度及缺氧的時間對於腦波的變化有所不同,最嚴重時會出現α-昏迷(α-com)、猝發-壓抑型腦波或平坦腦電圖(flat EEG)。當心律不整時,血液中可能會導致血栓的狀況,當血液中的小血塊進入到腦部時,可能會導致腦血關栓塞,會使腦波呈現局部性慢波。When the heart is ischemic, the blood delivered to the brain is insufficient, resulting in hypoxia in the brain. The severity of hypoxia in the brain and the time of hypoxia are different for brain waves. Alpha-coma (α-com), burst-repressed brain waves or flat EEG. When the heart rhythm is not complete, the blood may cause a thrombus condition. When a small blood clot in the blood enters the brain, it may cause cerebral blood to be embolized, causing the brain wave to exhibit a local slow wave.

腦部缺血或溢血的狀況時,腦部會去調整自主神經系統的活動,使得心律加快、呼吸急促,對心臟才加壓以送出更多氧氣,使腦部含氧量恢復平衡。When the brain is in a state of ischemia or hemorrhage, the brain will adjust the activity of the autonomic nervous system, so that the heart rate is accelerated, the breathing is rapid, and the heart is pressurized to deliver more oxygen, which restores the oxygen content of the brain.

為了徹底釐清此類病患的疾病史和危險因素,針對同時罹患冠心症和腦部血管狹窄的病患(第一群),和因重度冠狀動脈心臟病預備接受手術或是氣球擴張術的病患(第二群),以嘗試設計製作二十四小時攜帶式同步心電圖腦電波記錄儀器,將所得的訊號用以統整確定他們之間的一個相互關係。首要解決的目標就是腦電波訊號和心電圖訊號之間的時續相關性。此後希望能依據此關係,建立所以相關係數的回歸模式,相信這樣的一個模式,將不僅能夠有效的解釋上述手術後的神經科學併發症,更是預防此種併發症的重要基礎。此外針對原因不明的缺血性腦中風(第三群),長期被認為是與陣發性的心律不整(尤其是心房顫動)以及短暫行成的心內血栓有關。這樣的陣發性心房顫動雖然尚未被例行性的心電圖所察知,有可能引起的這樣缺血性腦中風。希望能夠用這樣二十四小時攜帶式同步心電圖腦電波記錄儀器,釐清這個問題。In order to thoroughly clarify the history and risk factors of such patients, patients with coronary heart disease and cerebral vascular stenosis (group 1), and surgery for severe coronary heart disease or balloon dilatation The patient (second group) tried to design and produce a 24-hour portable synchronous ECG brain wave recording instrument, and used the obtained signals to determine a relationship between them. The primary goal is the temporal correlation between the brainwave signal and the ECG signal. Since then, I hope to establish a regression model of the correlation coefficient based on this relationship. I believe that such a model will not only effectively explain the neurological complications after the above surgery, but also be an important basis for preventing such complications. In addition, for the unexplained ischemic stroke (third group), long-term is considered to be associated with paroxysmal arrhythmia (especially atrial fibrillation) and transient intracardiac thrombosis. Such paroxysmal atrial fibrillation, although not yet known by routine electrocardiogram, may cause such ischemic stroke. I hope that I can use this 24-hour portable synchronous ECG brain wave recording instrument to clarify this problem.

因此,如何針對上述問題而提出一種新穎可記錄生理訊號之醫療裝置,其可同步紀錄心電圖與腦波信號的準確性於同一台電腦的螢幕檢視心電訊號與腦波訊號,以方便醫生進行心電訊號(ECG)與腦波訊號(EEG)的相關性分析。Therefore, how to solve the above problems and propose a novel medical device capable of recording physiological signals, which can simultaneously record the accuracy of the electrocardiogram and the brain wave signal on the screen of the same computer to view the electrocardiogram signal and the brain wave signal, so as to facilitate the doctor to carry out the heart. Correlation analysis between electrical signal (ECG) and brain wave signal (EEG).

本發明之目的之一,在於提供一種可記錄生理訊號之醫療裝置,其可同時偵測並記錄人體之心電訊號與腦波訊號,以方便供醫生進行分析疾病。One of the objects of the present invention is to provide a medical device capable of recording physiological signals, which can simultaneously detect and record the ECG signals and brain wave signals of the human body, so as to facilitate analysis of diseases by doctors.

本發明之目的之一,在於提供一種可記錄生理訊號之醫療裝置,其可分析人體之心電訊號與腦波訊號的相關性,以方便供醫生進行分析疾病。One of the objects of the present invention is to provide a medical device capable of recording a physiological signal, which can analyze the correlation between the human body's electrocardiogram signal and the brain wave signal, so as to facilitate the analysis of the disease by the doctor.

本發明之可紀錄生理訊號之醫療裝置包括一腦波偵測電路、一心電偵測電路、一微控制電路與一儲存電路。腦波偵測電路偵測人體之腦部而產生一腦波訊號,心電偵測電路偵測人體之心臟而產生一心電訊號,微控制電路接收腦波訊號與心電訊號,產生一控制訊號,儲存單元依據控制訊號,儲存腦波訊號與心電訊號。其中,心電訊號關聯於腦波訊號。The medical device capable of recording physiological signals of the present invention comprises a brain wave detecting circuit, an electrocardiogram detecting circuit, a micro control circuit and a storage circuit. The brain wave detection circuit detects the brain of the human body to generate a brain wave signal, and the electrocardiogram detection circuit detects the heart of the human body to generate an ECG signal, and the micro control circuit receives the brain wave signal and the ECG signal to generate a control signal. The storage unit stores the brain wave signal and the ECG signal according to the control signal. Among them, the ECG signal is associated with the brain wave signal.

再者,本發明之可紀錄生理訊號之醫療裝置更包括一分析單元,依據控制訊號而接收腦波訊號與心電訊號,以分析腦波訊號與心電訊號,而產生一分析訊號供醫生進行分析疾病。Furthermore, the medical device capable of recording the physiological signal of the present invention further comprises an analyzing unit for receiving the brain wave signal and the electrocardiogram signal according to the control signal to analyze the brain wave signal and the electrocardiogram signal, and generating an analysis signal for the doctor to perform. Analyze the disease.

茲為使 貴審查委員對本發明之結構特徵及所達成之功效有更進一步之瞭解與認識,謹佐以較佳之實施例及配合詳細之說明,說明如後:請參閱第一圖,其為本發明之一較佳實施例之方塊圖。如圖所示,本發明之可記錄生理訊號之醫療裝置,其包括一腦波偵測電路10、一心電偵測電路12、一類比數位轉換電路20,22、一微控制電路30與一儲存單元40。腦波偵測電路10,用於偵測一人體之腦部而產生一腦波訊號,其中請一併參閱第二圖,其為本發明之腦波偵測電路的方塊圖,如圖所示,腦波偵測電路10包含一電極模組100、一第一放電路110、一濾波電路120與一第二放大電路130。電極模組100包含六個電極,其平均分佈於人體之腦部(如第三圖所示),即平均分佈腦部之Fp1、Fp2、F3、F4、C3、C4共六點,並分為左右兩端,左端以Fp1、F3、C3為正極(Vin+),以A1為負極(Vin-),右端以Fp2、F4、C4為正極(Vin+),以A2為負極(Vin-),以下巴作參考接地點。如此,可平均偵測腦部的腦波訊號,以完全了解腦部各部位的狀態。In order to provide a better understanding and understanding of the structural features and the efficacies of the present invention, please refer to the preferred embodiment and the detailed description as follows: please refer to the first figure, which is A block diagram of a preferred embodiment of the invention. As shown in the figure, the medical device capable of recording physiological signals includes a brain wave detecting circuit 10, an electrocardiogram detecting circuit 12, an analog digital converting circuit 20, 22, a micro control circuit 30 and a storage device. Unit 40. The brain wave detecting circuit 10 is configured to detect a brain of a human body to generate a brain wave signal, wherein please refer to the second figure, which is a block diagram of the brain wave detecting circuit of the present invention, as shown in the figure. The brain wave detecting circuit 10 includes an electrode module 100, a first discharging circuit 110, a filtering circuit 120 and a second amplifying circuit 130. The electrode module 100 comprises six electrodes, which are evenly distributed in the brain of the human body (as shown in the third figure), that is, an average distribution of six points Fp1, Fp2, F3, F4, C3, and C4 in the brain, and is divided into six points. Left and right ends, left end with Fp1, F3, C3 as positive (Vin+), A1 as negative (Vin-), right end with Fp2, F4, C4 as positive (Vin+), A2 as negative (Vin-), hereinafter As a reference grounding point. In this way, the brain wave signal of the brain can be detected on average to fully understand the state of various parts of the brain.

第一放大電路110為一儀表放大器,由於腦波訊號非常微小,使得訊號容易不穩定,造成腦波常常量測不到,所以第一放大電路110接收電極模組100所偵測的腦波訊號,以放大微弱的生理訊號,即腦波訊號。濾波電路120接收第一放大電路110所放大的腦波訊號,以過濾腦波訊號的雜訊,其中濾波電路120更包括一高通濾波器122、一低通濾波器124與一帶拒濾波器126。高通濾波器122接收第一放大電路110所放大的腦波訊號,並濾除腦波訊號之低頻漂移的成分,避免在量測時受到低頻的干擾。其中,高通濾波器122為一巴特渥斯(Butterworth)低通濾波器。由於考慮到盡可能保留腦波訊號的成份,並除去不必要的高頻雜訊。所以更設置低通濾波器124,其接收過濾高通濾波器122所過濾後之腦波訊號的高頻成分,以濾除腦波訊號之低頻漂移的成分,避免在量測時受到高頻的干擾,主要為60 Hz家電雜訊。腦波訊號的頻率成份大約落在1~30Hz,所以截止頻率設在30Hz,一方面會把60 Hz的訊號先作一次的濾除,作為60 Hz的前導濾波器。其中,低通濾波器124係為一Butterworth四階低通濾波器。帶拒濾波器126過濾低通濾波器122過濾後之腦波訊號的一雜訊頻率,以過濾雜訊頻率為60Hz的電源雜訊作濾除。第二放大電路130接收濾波電路120所過濾之腦波訊號,並放大腦波訊號。The first amplifying circuit 110 is an instrumentation amplifier. Since the brain wave signal is very small, the signal is easily unstable, and the brain wave is often not measured. Therefore, the first amplifying circuit 110 receives the brain wave signal detected by the electrode module 100. To amplify the weak physiological signal, the brain wave signal. The filter circuit 120 receives the brain wave signal amplified by the first amplifying circuit 110 to filter the noise of the brain wave signal. The filter circuit 120 further includes a high pass filter 122, a low pass filter 124 and a band reject filter 126. The high-pass filter 122 receives the brain wave signal amplified by the first amplifying circuit 110, and filters out the components of the low-frequency drift of the brain wave signal to avoid low-frequency interference during measurement. The high pass filter 122 is a Butterworth low pass filter. Because it takes into account the components of the brainwave signal as much as possible, and removes unnecessary high-frequency noise. Therefore, a low-pass filter 124 is further disposed, which receives the high-frequency component of the brain wave signal filtered by the high-pass filter 122 to filter out the low-frequency drift component of the brain wave signal, thereby avoiding high-frequency interference during measurement. Mainly for 60 Hz home appliance noise. The frequency component of the brainwave signal falls at about 1~30Hz, so the cutoff frequency is set at 30Hz. On the one hand, the 60Hz signal is filtered out first, as a 60Hz pilot filter. The low pass filter 124 is a Butterworth fourth-order low pass filter. The rejection filter 126 filters a noise frequency of the brain wave signal filtered by the low pass filter 122 to filter the power noise of the noise frequency of 60 Hz. The second amplifying circuit 130 receives the brain wave signal filtered by the filter circuit 120 and amplifies the brain wave signal.

心電偵測電路12偵測人體之心臟而產生一心電訊號,其中,心電偵測電路12係將電極致於人體之RA以及LA(如第四圖所示)上,而與腦波偵測電路10共用下巴當作參考接地點。由於心電偵測電路12與腦波偵測電路10的電路原理相同,故此不再多加贊述。The electrocardiogram detecting circuit 12 detects the heart of the human body to generate an electrocardiogram signal, wherein the electrocardiogram detecting circuit 12 causes the electrodes to be applied to the RA and LA of the human body (as shown in the fourth figure), and the brain wave detection The measuring circuit 10 shares the chin as a reference grounding point. Since the circuit principle of the electrocardiogram detecting circuit 12 and the brain wave detecting circuit 10 are the same, no further comments are made.

類比數位轉換電路20,22,係分別接收腦波訊號與心電訊號,以分別轉換腦波訊號與心電訊號之類比訊號為數位訊號,並傳送至微控制電路30。微控制電路30接收腦波訊號與心電訊號之數位訊號,以產生一控制訊號。儲存單元40接收控制訊號,以儲存記錄腦波訊號與心電訊號。再者,由於本發明之醫療裝置體積小,如此方便攜帶並可同時量測並記錄腦波訊號與心電訊號。The analog digital conversion circuits 20 and 22 respectively receive the brain wave signal and the electrocardiogram signal to respectively convert the analog signals of the brain wave signal and the electrocardiogram signal into digital signals, and transmit the signals to the micro control circuit 30. The micro control circuit 30 receives the digital signals of the brain wave signal and the electrocardiogram signal to generate a control signal. The storage unit 40 receives the control signal to store and record the brain wave signal and the ECG signal. Moreover, since the medical device of the present invention is small in size, it is convenient to carry and can simultaneously measure and record brain wave signals and ECG signals.

此外,本發明之可記錄生理訊號之醫療裝置更包括一顯示裝置42與一輸入單元44。顯示裝置42耦接微控制電路30,接收心電訊號與腦波訊號,以用來即時顯示心電訊號與腦波訊號,可讓使用者選擇欲顯示的生理訊號,在顯示裝置42之顯示螢幕的左上角顯示目前的醫療裝置的狀態,告訴使用者目前顯示裝置42在已經在待命中、傳送資料中或是擷取訊號中(如第五圖所示)。其中,顯示裝置42為一液晶顯示器(Liquid Crystal Display,LCD)。In addition, the medical device capable of recording physiological signals of the present invention further includes a display device 42 and an input unit 44. The display device 42 is coupled to the micro control circuit 30 for receiving the ECG signal and the brain wave signal for displaying the ECG signal and the brain wave signal in real time, and allowing the user to select the physiological signal to be displayed, and displaying the screen on the display device 42. The upper left corner shows the status of the current medical device, telling the user that the display device 42 is currently in standby, transmitting data, or capturing signals (as shown in Figure 5). The display device 42 is a liquid crystal display (LCD).

再者,在顯示裝置42的介面化選單,供使用者搭配一輸入單元44做系統的操作。輸入單元44耦接微控制電路30,傳送一輸入訊號,控制微控制電路30動作,輸入單元44為一鍵盤裝置,以供使用者與醫療裝置間的溝通介面,能讓使用者輕易的由鍵盤輸入對醫療裝置作控制,如第六圖所示,鍵盤裝置的功能有0:開始擷取訊號,1:停止擷取訊號,2:傳輸,3:系統重置,4:選擇通道。Furthermore, an interface menu of the display device 42 is provided for the user to perform an operation with the input unit 44. The input unit 44 is coupled to the micro control circuit 30, and transmits an input signal to control the operation of the micro control circuit 30. The input unit 44 is a keyboard device for the user to communicate with the medical device, so that the user can easily use the keyboard. The input controls the medical device. As shown in the sixth figure, the function of the keyboard device is 0: start capturing signal, 1: stop capturing signal, 2: transmission, 3: system reset, 4: selecting channel.

分析單元50接收依據控制訊號,接收腦波訊號與心電訊號,分析腦波訊號與心電訊號間的相關性,而產生一分析訊號,以方便供醫生進行分析疾病。其中,請一併參閱第七圖與第八圖,其分別為本發明之分析單元之方塊圖與分析單元分析心電訊號與腦波訊號之流程圖。如圖所示,本發明之分析單元50包括一第一運算單元54、一第二運算單元56與一整合單元58。第一運算單元54接收心電訊號並運算心電訊號,而產生至少一心電參數,其中心電參數為α參數(α activity)、β參數(β activity)、δ參數(δ activity)與θ參數(θ activity)。再者,第一運算單元54如何運算心電訊號而得知心電參數,以下係配合第八圖加以說明,首先第一運算單元54接收心電訊號後(步驟S10),會把心電訊號作特徵化(步驟S11),目的是在於便於我們找出心電訊號中R波的位置,再來計算R-R區間(R-R Interval)的時間(如步驟S12),透過步驟S13,重新取樣(Resample)後,再經由步驟S15,以快速傅立葉轉換(FFT)而求得心電參數,即心率變異度中的參數。再以時間的同步與腦波的頻譜成份做比較與觀察(如步驟S18)。由於本發明在此實施例是採用2048點(如步驟S14)的快速傅立葉轉換,所以必須先行收集2048個採樣點後才能進行功率頻譜的計算。在計算完心率變異度功率頻譜後,可以在功率頻譜圖中,0到0.4Hz的頻率範圍內找到數個波峰,本研究將頻率由0.04至0.15Hz的頻帶內的能量,定義為低頻帶能量(low frequency power,LFP),另外由0.15至0.4Hz的頻帶內的能量定義為高頻帶(high frequency power,HFP),而0至0.5 Hz定義為總頻帶TP_hrv(hrv totalpower)。The analyzing unit 50 receives the brain wave signal and the ECG signal according to the control signal, analyzes the correlation between the brain wave signal and the ECG signal, and generates an analysis signal for the doctor to analyze the disease. Please refer to the seventh diagram and the eighth diagram together, which are respectively a block diagram and an analysis unit of the analysis unit of the present invention for analyzing the flow chart of the electrocardiogram signal and the brain wave signal. As shown, the analysis unit 50 of the present invention includes a first operation unit 54, a second operation unit 56, and an integration unit 58. The first operation unit 54 receives the ECG signal and calculates the ECG signal to generate at least one ECG parameter, and the central electrical parameters are α parameter (α activity), β parameter (β activity), δ parameter (δ activity) and θ parameter. (θ activity). Furthermore, the first arithmetic unit 54 calculates the electrocardiogram signal to know the electrocardiogram parameter. The following is described in conjunction with the eighth figure. First, after the first arithmetic unit 54 receives the electrocardiogram signal (step S10), the ECG signal is used. Characterization (step S11), the purpose is to facilitate us to find the position of the R wave in the ECG signal, and then calculate the R-R interval (R-R Interval) time (as in step S12), and re-sample through step S13. After (Resample), the electrocardiographic parameter, that is, the parameter in the heart rate variability, is obtained by fast Fourier transform (FFT) via step S15. The time synchronization is compared with the spectral components of the brain waves (step S18). Since the present invention employs a fast Fourier transform of 2048 points (step S14) in this embodiment, it is necessary to collect 2048 sample points before the power spectrum can be calculated. After calculating the heart rate variability power spectrum, several peaks can be found in the power spectrum diagram in the frequency range of 0 to 0.4 Hz. In this study, the energy in the frequency band from 0.04 to 0.15 Hz is defined as the low band energy. (low frequency power, LFP), additionally, the energy in the frequency band of 0.15 to 0.4 Hz is defined as high frequency power (HFP), and 0 to 0.5 Hz is defined as the total frequency band TP_hrv (hrv total power).

第二運算單元54運算腦波訊號,產生至少一腦波參數,即第二運算單元54利用腦波的原始訊號,並配合第一運算單元52而採用2048點(如步驟S31所示),透過快速傅立葉轉換(如步驟S32),得到功率頻譜後,則往後移動40點再取固定長度以得到下一段資料,如此可以達到0.2秒的時間解析度,持續至30個心跳結束(如步驟S20所示)。再將這些所得到的功率頻譜做平均化(如步驟S35),以計算出腦波參數,其中,以0.4至4Hz的頻帶內的能量定義為δ參數(δ activity),4至8Hz的頻帶內的能量定義為θ參數(θ activity),8至12Hz的頻帶內的能量定義為α參數(α activity),而12至30Hz的頻帶內的能量定義為(β activity),0至30Hz的頻帶內的能量定義為TP_eeg(EEG total power),每30個心跳計算一筆參數資料,參數包含R-R區間(R-R Interval)、心率變異度(HRV)中的LFP、HFP、TP_hrv以及腦波的δ、θ、α、β activity、TP_eeg參數。重複以上步驟,每次更新30個心跳,即可得到腦波時頻域功率頻譜分析圖。整合單元58,係接收並整合心電參數與腦波參數,產生至少一相關參數。即利用皮耳森(PEARSON)相關度分析找出皮耳森相關係數,此係數為從-1.0到1.0的無方向性的係數,用以反應出兩個資料組之間線性關係的程度。The second operation unit 54 calculates the brain wave signal to generate at least one brain wave parameter, that is, the second operation unit 54 uses the original signal of the brain wave, and cooperates with the first operation unit 52 to adopt 2048 points (as shown in step S31). Fast Fourier transform (such as step S32), after obtaining the power spectrum, then move 40 points backwards and then take a fixed length to get the next piece of data, so that the time resolution of 0.2 seconds can be reached, and the end of 30 heartbeats (such as step S20) Shown). These obtained power spectra are then averaged (step S35) to calculate brainwave parameters, wherein the energy in the frequency band of 0.4 to 4 Hz is defined as the delta parameter (δ activity), in the frequency band of 4 to 8 Hz. The energy is defined as the θ parameter (θ activity), the energy in the frequency band of 8 to 12 Hz is defined as the α parameter (α activity), and the energy in the frequency band of 12 to 30 Hz is defined as (β activity), in the frequency band of 0 to 30 Hz. The energy is defined as TP_eeg (EEG total power), and a parameter data is calculated for every 30 heartbeats. The parameters include RR interval (RR Interval), heart rate variability (HRV), LFP, HFP, TP_hrv, and δ, θ of brain waves. α, β activity, TP_eeg parameters. Repeat the above steps, each time you update 30 heartbeats, you can get the brainwave time-frequency domain power spectrum analysis. The integration unit 58 receives and integrates the electrocardiographic parameters and the brain wave parameters to generate at least one related parameter. That is, Pearson correlation analysis is used to find the Pearson correlation coefficient, which is a non-directional coefficient from -1.0 to 1.0, which is used to reflect the degree of linear relationship between the two data sets.

承上所述,將正常人之整個睡眠的β參數與R-R區間做相關度分析,其相關度為-0.749,而將正常人之整個睡眠的δ參數與低頻帶能量(LF)做相關度分析,相關度也有-0.477。雖然δ參數與LF相關度只有-0.447,但其δ參數與LF整體的趨勢呈現相當成程度的負相關。所以本實施例特別把δ參數與LF拿出來以事件性做相關係數分析,分別各設一個事件閥值,δ參數閥值為0.20,LF設為0.06,分別與閥值比對,若超過閥值則設為1,沒超過閥值則設為0,意即超過閥值者為有δ參數事件發生,及LF活躍之時。計算完之後再做相關性分析,得到皮耳森相關係數結果為-0.608,呈現很高的負相關,可能為交感神經在熟睡時會受到抑制,在REM睡眠時交感神經會被活化。如此,藉由正常人之心電參數與腦波參數的相關性,而供供醫生進行分析人體的異常狀態。According to the above, the correlation between the β parameter of the whole person's sleep and the RR interval is analyzed, and the correlation is -0.749, and the correlation between the δ parameter of the whole person's sleep and the low-band energy (LF) is analyzed. The correlation also has -0.477. Although the correlation between δ parameter and LF is only -0.447, its δ parameter has a considerable degree of negative correlation with the overall trend of LF. Therefore, in this embodiment, the δ parameter and the LF are taken out to analyze the correlation coefficient by event, and an event threshold is set for each, the δ parameter threshold is 0.20, and the LF is set to 0.06, which is respectively compared with the threshold, if the valve is exceeded. The value is set to 1, and is set to 0 when the threshold is not exceeded, meaning that the threshold value is exceeded when the δ parameter event occurs, and when the LF is active. After the calculation, the correlation analysis was performed, and the results of the Pearson correlation coefficient were -0.608, which showed a high negative correlation. It may be that the sympathetic nerves are inhibited when they are asleep, and the sympathetic nerves are activated during REM sleep. In this way, the correlation between the electrocardiographic parameters of the normal person and the brain wave parameters is provided to the doctor for analyzing the abnormal state of the human body.

此外,本發明之醫療裝置可為一攜帶式醫療裝置,以持續記錄人體之腦波訊號與心電訊號,再透過一傳輸介面52耦接微控制電路30與分析單元50之間,傳輸腦波訊號與心電訊號至分析單元50,分析單元50可設置於一電腦系統中,以分析腦波訊號與心電訊號的相關性,如此,藉由長期記錄人體之腦波訊號與心電訊號於本發明之醫療裝置,以供使用者方便在家中進行紀錄,再提供給醫生進行分析並判斷病患的疾病。其中,傳輸介 面52為一週邊元件內連接(Peripheral Component Interconnect,PCI)數位輸出入卡、一萬用串列匯流排(Universal Serial Bus,USB)、一1394規格之傳輸介面、一有線區域網路(IEEE802.3)傳輸介面、一紅外線規格(IrDA)之傳輸介面或一藍芽規格(Bluetooth)之傳輸介面,上述僅為本實施例提供之傳輸介面的例子,但不侷限於上述所提之傳輸介面。In addition, the medical device of the present invention can be a portable medical device for continuously recording the brain wave signal and the electrocardiogram signal of the human body, and then coupled between the micro control circuit 30 and the analyzing unit 50 through a transmission interface 52 to transmit brain waves. The signal and the ECG signal are sent to the analysis unit 50. The analysis unit 50 can be disposed in a computer system to analyze the correlation between the brain wave signal and the ECG signal. Thus, by long-term recording of the brain wave signal and the ECG signal of the human body. The medical device of the present invention is convenient for the user to record at home, and then provided to the doctor for analysis and judgment of the disease of the patient. Among them, the transmission media The surface 52 is a Peripheral Component Interconnect (PCI) digital output card, a universal serial bus (USB), a 1394 specification transmission interface, and a wired area network (IEEE802. 3) The transmission interface, the transmission interface of an infrared specification (IrDA) or the transmission interface of a Bluetooth specification. The above is only an example of the transmission interface provided by the embodiment, but is not limited to the above-mentioned transmission interface.

綜上所述,本發明之可記錄生理訊號之醫療裝置,其藉由一腦波偵測電路與一心電偵測電路,以同時偵測人體之腦波訊號與心電訊號,並藉由一分析單元分析腦波訊號與心電訊號的相關性,以方便供醫生進行分析疾病。In summary, the medical device capable of recording a physiological signal of the present invention uses a brain wave detecting circuit and an electrocardiogram detecting circuit to simultaneously detect a brain wave signal and an electrocardiogram signal of the human body, and The analysis unit analyzes the correlation between brainwave signals and ECG signals to facilitate analysis of the disease by doctors.

本發明係實為一具有新穎性、進步性及可供產業利用者,應符合我國專利法所規定之專利申請要件無疑,爰依法提出發明專利申請,祈 鈞局早日賜准專利,至感為禱。The invention is a novelty, progressive and available for industrial use, and should meet the requirements of the patent application stipulated in the Patent Law of China, and the invention patent application is filed according to law, and the prayer bureau will grant the patent as soon as possible. prayer.

惟以上所述者,僅為本發明之一較佳實施例而已,並非用來限定本發明實施之範圍,舉凡依本發明申請專利範圍所述之形狀、構造、特徵及精神所為之均等變化與修飾,均應包括於本發明之申請專利範圍內。However, the above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention, and the shapes, structures, features, and spirits described in the claims are equivalently changed. Modifications are intended to be included in the scope of the patent application of the present invention.

1‧‧‧人體1‧‧‧ human body

10‧‧‧腦波偵測電路10‧‧‧ brain wave detection circuit

100‧‧‧電極模組100‧‧‧electrode module

110‧‧‧第一放大電路110‧‧‧First amplification circuit

12‧‧‧心電偵測電路12‧‧‧ ECG detection circuit

120‧‧‧濾波電路120‧‧‧Filter circuit

122‧‧‧高通濾波器122‧‧‧High-pass filter

124‧‧‧低通濾波器124‧‧‧Low-pass filter

126‧‧‧帶拒濾波器126‧‧‧Rejection filter

130‧‧‧第二控制電路130‧‧‧Second control circuit

20‧‧‧類比數位轉換電路20‧‧‧ analog digital conversion circuit

22‧‧‧類比數位轉換電路22‧‧‧ analog digital conversion circuit

30‧‧‧微控制電路30‧‧‧Micro Control Circuit

40‧‧‧儲存單元40‧‧‧ storage unit

42‧‧‧顯示裝置42‧‧‧ display device

44‧‧‧輸入單元44‧‧‧ Input unit

50‧‧‧分析單元50‧‧‧Analysis unit

52‧‧‧傳輸單元52‧‧‧Transportation unit

54‧‧‧第一運算單元54‧‧‧First arithmetic unit

56‧‧‧第二運算單元56‧‧‧Second arithmetic unit

58‧‧‧整合單元58‧‧‧Integrated unit

第一圖為本發明之一較佳實施例之方塊圖;第二圖為本發明之腦波偵測電路之方塊圖;第三圖為本發明之腦波電極設置之示意圖;第四圖為本發明之心電電極設置之示意圖;第五圖為本發明之顯示裝置之顯示介面示意圖;第六圖為本發明之輸入單元之按鍵功能示意圖;第七圖為本發明之分析單元之方塊圖;以及第八圖為本發明之分析單元分析心電訊號與腦波訊號之流程圖。The first figure is a block diagram of a preferred embodiment of the present invention; the second figure is a block diagram of the brain wave detecting circuit of the present invention; the third figure is a schematic diagram of the brain wave electrode setting of the present invention; The schematic diagram of the display device of the present invention; the fifth diagram is a schematic diagram of the display interface of the display device of the present invention; the sixth diagram is a schematic diagram of the function of the button of the input unit of the present invention; And the eighth figure is a flow chart of analyzing the ECG signal and the brain wave signal by the analyzing unit of the present invention.

1‧‧‧人體1‧‧‧ human body

10‧‧‧腦波偵測電路10‧‧‧ brain wave detection circuit

12‧‧‧心電偵測電路12‧‧‧ ECG detection circuit

20‧‧‧類比數位轉換電路20‧‧‧ analog digital conversion circuit

22‧‧‧類比數位轉換電路22‧‧‧ analog digital conversion circuit

30‧‧‧微控制電路30‧‧‧Micro Control Circuit

40‧‧‧儲存單元40‧‧‧ storage unit

42‧‧‧顯示裝置42‧‧‧ display device

44‧‧‧輸入單元44‧‧‧ Input unit

50‧‧‧分析單元50‧‧‧Analysis unit

52‧‧‧傳輸單元52‧‧‧Transportation unit

Claims (18)

一種可記錄生理訊號之醫療裝置,其包含:一腦波偵測電路,偵測一人體之腦部,產生一腦波訊號;一心電偵測電路,偵測該人體之心臟,產生一心電訊號,該腦波偵測電路與該心電偵測電路同步擷取該腦波訊號與該心電訊號;一微控制電路,接收該腦波訊號與該心電訊號,產生一控制訊號;一儲存單元,接收該控制訊號,儲存該腦波訊號與該心電訊號;一顯示裝置,耦接該微控制電路,接收該心電訊號與該腦波訊號,以顯示該心電訊號與該腦波訊號;以及一分析單元,依據該控制訊號,接收該腦波訊號與該心電訊號,分析該腦波訊號與該心電訊號,產生一分析訊號,且其具有:一第一運算單元,運算該心電訊號,產生至少一心電參數;一第二運算單元,運算該腦波訊號,產生至少一腦波參數;以及一整合單元,接收並整合該心電參數與該腦波參數,產生至少一相關參數,該相關參數係反應該心電參數以及該腦波參數之間線性關係之程度;其中,該心電訊號關聯於該腦波訊號。 A medical device capable of recording a physiological signal, comprising: a brain wave detecting circuit for detecting a brain of a human body to generate a brain wave signal; an ECG detecting circuit for detecting the heart of the human body to generate an electrocardiogram signal The brain wave detecting circuit and the ECG detecting circuit synchronously capture the brain wave signal and the ECG signal; a micro control circuit receives the brain wave signal and the ECG signal to generate a control signal; Receiving the control signal to store the brain wave signal and the ECG signal; a display device coupled to the micro control circuit to receive the ECG signal and the brain wave signal to display the ECG signal and the brain wave And an analyzing unit, according to the control signal, receiving the brain wave signal and the ECG signal, analyzing the brain wave signal and the ECG signal, generating an analysis signal, and having: a first operation unit, the operation The ECG signal generates at least one ECG parameter; a second computing unit calculates the brain wave signal to generate at least one brain wave parameter; and an integration unit receives and integrates the ECG parameter and the brain wave parameter Generating at least a parameter related to the system parameters and the degree of anti ECG should be a linear relationship between the specifications of the electroencephalogram; wherein associated with the ECG signal to the brain wave signal. 如申請專利範圍第1項所述之醫療裝置,其中該相關參數之產生,係為該整合單元對該心電參數與該腦波參數分別設定一閥值,以透過該心電參數或該腦波參數是否超過該閥值而提供介於-0.1~1.0之無方向性係數。 The medical device according to claim 1, wherein the relevant parameter is generated by the integrating unit respectively setting a threshold value of the electrocardiographic parameter and the brain wave parameter to transmit the ECG parameter or the brain Whether the wave parameter exceeds the threshold provides a non-directional coefficient of -0.1 to 1.0. 如申請專利範圍第1項所述之醫療裝置,其更包括:一傳輸介面,耦接該微控制電路與該分析單元之間,傳輸該該腦波訊號與該心電訊號至該分析單元。 The medical device of claim 1, further comprising: a transmission interface coupled between the micro control circuit and the analysis unit, and transmitting the brain wave signal and the ECG signal to the analysis unit. 如申請專利範圍第3項所述之醫療裝置,其中該傳輸介面為一週邊元件內連接(Peripheral Component Interconnect,PCI)數位輸出入卡、一1394規格之傳輸介面、一有線區域網路(IEEE802.3)傳輸介面、一紅外 線規格(IrDA)之傳輸介面或一藍芽規格(Bluetooth)之傳輸介面。 The medical device of claim 3, wherein the transmission interface is a Peripheral Component Interconnect (PCI) digital output card, a 1394 specification transmission interface, and a wired area network (IEEE 802. 3) transmission interface, an infrared Line specification (IrDA) transmission interface or a Bluetooth transmission interface. 如申請專利範圍第1項所述之醫療裝置,其中該心電參數為頻率介於0~0.5Hz之一總頻帶能量(Total power,TP)、頻率介於0.04~0.15Hz之一低頻帶能量(Low Frequency power,LFP)或頻率介於0.15~0.4Hz之一高頻帶能量(High Frequency power,HFP)。 The medical device according to claim 1, wherein the electrocardiographic parameter is a low frequency band energy of a total frequency band (Total power, TP) with a frequency between 0 and 0.5 Hz and a frequency between 0.04 and 0.15 Hz. (Low Frequency power, LFP) or high frequency power (HFP) with a frequency between 0.15 and 0.4 Hz. 如申請專利範圍第1項所述之醫療裝置,其中該腦波參數係為頻率介於8~12Hz之α參數、頻率介於12~30Hz之β參數、頻率介於0.4~4Hz之δ參數以及頻率介於4~8Hz之θ參數。 The medical device according to claim 1, wherein the brain wave parameter is an α parameter with a frequency between 8 and 12 Hz, a β parameter with a frequency between 12 and 30 Hz, a δ parameter with a frequency between 0.4 and 4 Hz, and The θ parameter with a frequency between 4 and 8 Hz. 如申請專利範圍第1項所述之醫療裝置,其更包括:一類比數位轉換器,轉換該腦波訊號之類比訊號為數位訊號,並傳送至該微控制電路。 The medical device of claim 1, further comprising: an analog-to-digital converter, wherein the analog signal of the brain wave signal is converted into a digital signal and transmitted to the micro control circuit. 如申請專利範圍第1項所述之醫療裝置,其更包括:一類比數位轉換器,轉換該心電訊號之類比訊號為數位訊號,並傳送至該微控制電路。 The medical device of claim 1, further comprising: an analog-to-digital converter that converts the analog signal of the ECG signal into a digital signal and transmits the signal to the micro control circuit. 如申請專利範圍第1項所述之醫療裝置,其更包括:一輸入單元,耦接該微控制電路,傳送一輸入訊號,控制該微控制電路動作。 The medical device of claim 1, further comprising: an input unit coupled to the micro control circuit to transmit an input signal to control the operation of the micro control circuit. 如申請專利範圍第1項所述之醫療裝置,其中該顯示裝置為一液晶顯示器(Liquid Crystal Display,LCD)。 The medical device of claim 1, wherein the display device is a liquid crystal display (LCD). 如申請專範圍第1項所述之醫療裝置,其中該腦波偵測電路更包括:一電極模組,貼附並偵測該人體之該腦部,產生該腦波訊號;一第一放大電路,接收並放大該腦波訊號;一濾波電路,接收該第一放大電路所放大的該腦波訊號,並過濾該腦波訊號;以及一第二放大電路,接收該濾波電路所過濾之該腦波訊號,並放大該腦波訊號。 The medical device of claim 1, wherein the brain wave detecting circuit further comprises: an electrode module for attaching and detecting the brain of the human body to generate the brain wave signal; a circuit for receiving and amplifying the brain wave signal; a filter circuit receiving the brain wave signal amplified by the first amplifying circuit and filtering the brain wave signal; and a second amplifying circuit receiving the filter filtered by the filter circuit Brain wave signal and amplify the brain wave signal. 如申請專利範圍第11項所述之醫療裝置,其中該電極模組包括六個電 極。 The medical device of claim 11, wherein the electrode module comprises six electric devices pole. 如申請專利範圍第11項所述之醫療裝置,其中該該濾波電路更包括:一高通濾波器,過濾該腦波訊號之低頻成分;一低通濾波器,過濾該高通濾波器過濾後之該腦波訊號的高頻成分;以及一帶拒濾波器,過濾該低通濾波器過濾後之該腦波訊號的一雜訊頻率。 The medical device of claim 11, wherein the filtering circuit further comprises: a high-pass filter for filtering a low-frequency component of the brain wave signal; a low-pass filter filtering the high-pass filter for filtering a high frequency component of the brain wave signal; and a band rejection filter that filters a noise frequency of the brain wave signal filtered by the low pass filter. 如申請專利範圍第13項所述之醫療裝置,其中該雜訊頻率之頻率為60Hz。 The medical device of claim 13, wherein the frequency of the noise frequency is 60 Hz. 如申請專利範圍第1項所述之醫療裝置,其中該心電偵測電路更包括:一電極模組,貼附並偵測該人體之該心臟,產生該心電訊號;一第一放大電路,接收並放大該心電訊號;一濾波電路,接收該放大電路所放大的該心電訊號,並過濾該心電訊號;以及一第二放大減法電路,接收該濾波電路所過濾之該心電訊號,並放大該心電訊號。 The medical device of claim 1, wherein the electrocardiographic detection circuit further comprises: an electrode module for attaching and detecting the heart of the human body to generate the electrocardiogram signal; a first amplifying circuit Receiving and amplifying the ECG signal; a filter circuit receiving the ECG signal amplified by the amplifier circuit and filtering the ECG signal; and a second amplification subtraction circuit receiving the ECG filtered by the filter circuit Number and enlarge the ECG signal. 如申請專利範圍第15項所述之醫療裝置,其中該濾波電路更包括:一高通濾波器,過濾該心電訊號之低頻成分;一低通濾波器,過濾該高通濾波器過濾後之該心電訊號的高頻成分;以及一帶拒濾波器,過濾該低通濾波器過濾後之該心電訊號的一雜訊頻率。 The medical device of claim 15, wherein the filtering circuit further comprises: a high-pass filter for filtering a low-frequency component of the ECG signal; and a low-pass filter for filtering the core of the high-pass filter after filtering a high frequency component of the electrical signal; and a rejection filter that filters a noise frequency of the ECG signal filtered by the low pass filter. 如申請專利範圍第16項所述之醫療裝置,其中該雜訊頻率之頻率為60Hz。 The medical device of claim 16, wherein the frequency of the noise frequency is 60 Hz. 如申請專利範圍第1項所述之醫療裝置,其中該儲存單元為一快閃記憶體(Flash Memory)。 The medical device of claim 1, wherein the storage unit is a flash memory.
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